Arterial cooling elements for use with a cervical immobilization collar

ABSTRACT

A kit for cooling the blood in the carotid arteries includes a cervical immobilization collar and a cooling element. The cooling element may include a body-facing panel attached on a body-facing surface to a lining layer, an outward-facing panel, and cooling material disposed between the body-facing panel and the outward facing panel. The cooling material may comprise urea and Carbamakool™ in an amount sufficient to produce a temperature of 20° F. to 35° F. within a minute of activation when measured on the body-facing surface of the body-facing panel.

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/913,412, filed Oct. 27, 2010, which is acontinuation-in-part of U.S. Pat. No. 7,846,118, filed Apr. 24, 2009,which is a continuation of U.S. patent application Ser. No. 11/162,922,filed Sep. 28, 2005, now abandoned.

BACKGROUND OF INVENTION

The invention integrates technologies relating to cervicalimmobilization and to therapeutic induction of mild cerebral hypothermiaby transcutaneous cooling of oxygenated blood flowing through carotidarteries.

Cervical immobilization collars are often used by first-responders, suchas EMTs, to stabilize the neck, head, and spine of a patient immediatelyafter a trauma has occurred. While this procedure is generally effectiveto prevent further injury, it is helpful to begin to treat the patient'strauma before reaching the hospital. One method of treatment may includecooling the patient's brain. Brain cooling, i.e., reducing braintemperatures by as little as one or two degrees Celsius, produces aneuroprotective effect against deleterious responses associated withbrain injuries. This mild cerebral hypothermia inhibits the release ofneuroexcitetory amino acids (e.g., aspartate and glutamine), therebyinterrupting the cascading effects of the inflammatory response. Theneuroprotective effect is most pronounced if brain cooling is affectedas soon as possible following an injury.

Protocols for first responders generally do not incorporate effectiveprocedures for initiating brain cooling. For example, it is known toapply cold packs to the patient's body, to the groin, skull, and underthe arm. This type of cooling, however, imparts systemic cooling, ratherthan selective cooling, and may not effectively drop the temperature ofthe patient's brain.

SUMMARY OF INVENTION

A kit for cooling the blood in the carotid arteries includes a coolingelement and a cervical immobilization collar. The cooling elementincludes a body-facing panel, an outward-facing panel, and a coolingmaterial disposed between the body-facing panel and the outward facingpanel. The cooling material may be comprised of urea and Carbamakool.The cooling material is capable of producing a temperature of 20° F. to35° F. within a minute of activation when measured on the body-facingsurface of the body-facing panel and may be capable of maintaining thetemperature for a period of about 15 to about 30 minutes. The cervicalimmobilization collar may include a substantially annular supportstructure with an extended axial length and an anterior opening.

DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is perspective view of a cervical immobilization collar.

FIG. 2 is a top view of a the cervical immobilization collar.

FIG. 3 is a front view of the cervical immobilization collar.

FIG. 4 is a top view of a cooling element for use in the cervicalimmobilization collar.

FIG. 5 is a graphical representation of the temperatures obtained by theactivated cooling element over time.

FIG. 6 is a top view of a cooling element for use with a neck band.

FIG. 7 is a rear view of the cervical immobilization collar.

DETAILED DESCRIPTION

A cervical immobilization collar 10 may be used to stabilize a patient'sspine, neck, and head immediately following a trauma. As shown in FIGS.1-3 and 7, a cervical immobilization collar 10 for use with coolingelements may generally include a substantially annular support structure12 with an anterior portion 16, which wraps around the front of thepatient's neck, and a posterior portion 18, which wraps around the backof the patient's neck. The anterior portion 16 and the posterior portion18 may be formed of a single piece of material. In an alternativeembodiment, the anterior portion 16 and posterior portion 18 may beseparate components connected on one or both sides of the neck by ajoint or by an attachment mechanism, such as a hook and loop fastener.The substantially annular support structure 12 can be formed (preferablyby pour or injection molding) from a variety of materials includingplastics, polymers, or carbon or poly-paraphenylene terephthalamidefiber. In one embodiment, the annular support structure 12 comprisesSCLAIR® 2712 high density polyethylene, manufactured by NOVA Chemicalssupplied by Entec Polymers.

Referring to FIGS. 2 and 3, a hook and loop fastener strap 20 (as shownin FIG. 3) extends from a distal end 22 of the posterior portion 18 forreleasably engaging a mating hook-and-loop fastener patch (not shown)mounted on the proximal end 24 of the anterior portion 16 of thesubstantially annular support structure 12.

The anterior portion 16 of the substantially annular support structure12 may include cheek support structures 26. The cheek support structures26 may generally extend vertically from the either side of the chin rest14 and are configured to cover the area generally associated with thepatient's cheek. The cheek support structures 26 may be used to preventsignificant rotational or lateral movement of the patient's head. Thecheek support structures 26 may be formed integrally as a part of thesubstantially annular support structure 12, as shown, or may be formedseparately and mounted on to the substantially annular support structure12 with an appropriate adhesive or attachment mechanism. In anotherembodiment (not shown), the annular support structure 12 may not includecheek supports.

Referring again to FIG. 1, the cervical immobilization collar 10 alsoincludes an anterior opening 28 in the anterior portion 16 of thesubstantially annular support structure 12. The anterior opening 28 isdefined by the frame of the substantially annular support structure 12.Traditional neck braces may include an opening in the front of thebrace, but the opening is generally only large enough to provide accessto the patient's trachea in a case of a blocked airway. Alternatively,the anterior opening 28 in the cervical immobilization collar 10 isdesigned to traverse the front of the patient's neck, exposing both ofthe patient's carotid artery regions, as opposed to only the trachearegion.

As shown in FIG. 2, the cervical immobilization collar 10 also includesa door 30 that covers the anterior opening 28. In this embodiment, afirst edge portion of the door 30 is attached to the frame of thesubstantially annular support structure 12 at or about one end, or afirst edge portion, of the anterior opening 28 with a hinge 32, or otherappropriate fastening mechanism. As shown in FIGS. 1 and 2, in oneembodiment, a two part hinge may be used. In this embodiment, the firstpart of the hinge 34 may be integrally formed as part of the frame ofthe substantially annular support structure 12. Specifically, the firstpart of the hinge 34 may comprise from one, and preferably three,elastically deformable flanges. The second part of the hinge 36 may beintegrally formed as part of the first edge portion of the door 30. Thesecond part of the hinge 36 may snapped in to place within the firstpart of the hinge 34 by deforming the flanges. Once snapped in place,the second part of the hinge 36 is rotatable within the flanges of thefirst part of the hinge 34 so that the door 30 may be opened and closed,relative to the frame of the substantially annular support structure 12.In another embodiment, the hinge 32 may be a living hinge (not shown)that is integrally formed between the first edge portion of the door 30and the frame of the annular support structure 12.

A second edge portion of the door 30 may be fastened to the frame of thesubstantially annular support structure 12 at a second edge portion ofthe anterior opening 28 with second hook and loop fastener strap 38(shown in FIG. 3), which extends from the second edge portion of thedoor 30, and a mating hook-and-loop fastener patch (not shown) mountedon or about the frame of the substantially annular support structure 12at or near the second edge portion of the anterior opening 28. Theclosure may also be effectuated with a snap fit mechanism; pressure fitmechanisms, buttons, latches, adhesives, or other appropriate fasteningmechanism.

As discussed above, the anterior opening 28 extends substantially acrossthe majority of the anterior portion 16 of the substantially annularsupport structure 12. The immobilization collar 10, however, must bestrong enough to support the patient's neck and prevent flexion, ormovement in which the chin is lowered down toward the chest. Intraditional neck braces, this strength is provided by the structuralmaterial between the chin rest and the bottom of the brace. However, thelarge anterior opening 28, and lack of structural material between thechin rest 14 and the bottom of the collar 10, may compromise thestrength and support provided by the immobilization collar 10,particularly in the vertical plane. Thus, the patient may be able tomove their head up and down, even when wearing the collar 10. In orderto provide the needed support and, thus, significantly hinder thepatient's ability to move their head up and down, support members arebuilt into the substantially annular support structure 12.

As shown in FIG. 1, a horizontally protruding ledge 40 may extendperpendicularly from a bottom edge 42 of the anterior portion of theannular support structure 12.

In one embodiment, the ledge 40 may be integrally formed as part of theannular support structure 12 and may preferably extend across the entireanterior portion 16 of the frame of the substantially annular supportstructure 12. Similarly, the door 30 may include a shelf 44 that extendsperpendicularly from the top edge of the door 30, as shown in FIG. 1,inward toward the patient's body. The shelf 44 may be integrally formedas part of the door 30. The shelf 44 may also include gaps 46 that allowthe shelf 44, as part of the door 30, to bend during use.

When the door 30 is closed, as shown in FIG. 3, and the patient attemptsto move their head down, the bottom 48 of the door 30 abuts the ledge40. Similarly, the shelf 44 (shown in FIGS. 1 and 2) on the door 30 willabut the bottom of the chin rest 14, hindering the downward movement andeffectively using the door 30 as the structural material between thechin rest 14 and the bottom of the collar 10.

Lateral ribs 50 a and 50 b may be included as well to add structuralsupport to the anterior portion of the annular support structure 12. Asshown in FIGS. 2 and 3, the lateral ribs 50 a and 50 b are integrallyformed on the exterior surface of the annular support structure 12 andextend from under the apex of the cheek support structures 26 and abutthe ledge 40. As shown in FIG. 3, lateral rib 50 b may be formed of twoseparate pieces, a first extending from the apex of the cheek support 26and a second extending up from the ledge 40, to accommodate the hook andloop fastener on the door 30.

The cervical immobilization collar 10 may be used in conjunction with acooling element 52. The cooling element 52, shown in FIG. 4, may have ashape that is substantially similar, or slightly larger, than the shapeof the anterior opening 28, although the shape may take other forms, andmay have a flexible, rigid, or quasi-rigid structure. The coolingelement 52 may include a body-facing panel 54 and an outward-facingpanel (not shown). In one embodiment, the body-facing panel 54 and theoutward-facing panel may be secured at their edges with a heat-activatedadhesive seal or other appropriate sealing mechanism. The coolingelement 52 may be separate from or integral with the cervicalimmobilization collar 10.

In one embodiment, the cooling element 52 is separate from the cervicalimmobilization collar 10. In this embodiment, the body-facing panel 54and the outward-facing panel may be formed of one sheet of material thatis folded in half and sealed at its open edges or two sheets of materialthat are sealed along all of their edges. The cooling element 52 mayinclude cooling material that produces endothermic reactions, previouslychilled gels, or other materials having the capacity to absorb heat.Once the components of the endothermic packs are mixed or the element isotherwise activated, the cooling element 52 is preferably put intoimmediate use.

In one embodiment, the panels may include a lining layer, that covers atleast the body-facing panel 54 of the cooling element 52 that comes intocontact with the patient's neck. In one embodiment, the lining layersubstantially covers the body-facing panel 54 of the cooling element 52.In another embodiment, both panels of the cooling element 52 are coveredwith the lining layer. The lining layer may be made of fabric, forexample a non-woven material. It should be appreciated that the lininglayer may be made of any material capable of providing comfort andpreventing skin irritation, skin degradation, and potential frostbite.The lining layer may be adhered to the panels or may be detachable.

In one embodiment, the panels of the cooling element include a lininglayer comprised of a non-woven material that is adhered to one or bothof the panels. The panels may be comprised of a film-like material. Inone example, a 0.007 mm non-woven lining layer is laminated onto a 2.5mm linear low density white polyethylene film to form both panels of thecooling element 52. The water permeability of the panels may be 0.41grams/100 sq in/24 hrs and the oxygen gas permeability may be less than9.0 cc/100 sq in/24 hrs.

In this embodiment, the cooling element 52 may be approximately 10 toabout 12 inches long and may include about 90 to about 110 g urea, about45 to about 55 g Carbamakool™, and water. In another embodiment, thecooling element 52 may be about 10 inches long and include about 100 gurea, about 50 g Carbamakool™, and water. In another embodiment, thecooling element 36 may be about 11 inches long and include about 110 gurea, about 55 g Carbamakool™, and water. In these embodiments, thecrystal like urea and Carbamakool™ are mixed together and sealed betweenthe panels of the cooling element 52. In this embodiment, the coolingelement 52 also includes a liquid-filled, preferably water, frangiblepacket (not shown). The liquid-filled packet is also sealed between thepanels of the cooling element 52. To activate the cooling element 52, auser, applying pressure to the cooling element 52, ruptures the packet,which wets the urea and Carbamakool™. The user then shakes the coolingelement 52 to mix the ingredients and initiate an endothermic reaction.

The cooling material in the cooling element preferably reaches atemperature of 20° F. to 45° F., desirably 25° F. to 35° F., within aminute of activation, and maintains the temperature for a period ofabout 10 to about 30 minutes, preferably from about 15 to about 20minutes. Suitable cooling materials for the cooling elements 52 areavailable from Nortech Labs, 125 Sherwood Avenue Farmingdale, N.Y.11735.

Unlike known cold packs, which come with instructions directing theusers not to place cold pack directly on the patient's skin, the coolingelement 52, including a fabric lining layer laminated to the panels,allows the user to place the cooling element 52 directly on the skin ofthe patient for up to 20 to 30 minutes. Moreover, laminating, orotherwise adhering, the fabric lining layer to the panels film preventsthe cooling element 52 from slipping out of place and away from thecarotid arteries when in use against the patient's neck.

The reduced temperature produced by the mixture of urea, Carbamakool™,and water is measured on the outer surface of the cooling element 52. Inother words, the temperature that the patient comes in contact with ismeasured to evaluate the amount of heat extraction effectuated by thecooling element 52. Using a fabric lining layer, however, insulates thecooling element 52, and therefore the internal capacity of the coolingelement 52 and the amount of urea and Carbamakool™ used therein isimportant to properly extract heat from the patient's carotid arteries.

Example

One lot of cooling elements 52, samples A-E, were tested. Each samplewas 10 inches in length and included 100 g urea, and 50 g Carbamakool™.Both panels of samples A-E were comprised of a 0.007 mm non-woven lininglayer laminated onto a 2.5 mm linear low density white polyethylenefilm.

The samples were activated by squeezing the samples to break awater-filled frangible packet that was sealed within the panels, thenshaking each sample ten (10) times. The samples were folded and insertedinto 16 oz Styrofoam cups. The ambient temperature, 68.7° F., wasrecorded and thermocouples were place in the fold of each coolingelement about one inch from the bottom of the cups. Temperature readingswere recorded once a minute with the last recording made after 30minutes. Each cooling element was re-shaken after a two minute elapsedtime. The results are shown in Table I below:

TABLE I Time (min) Sample A Sample B Sample C Sample D Sample E 1 68.768.7 68.7 68.7 68.7 2 42.0 27.3 30.0 30.7 27.3 3 35.0 24.8 28.5 27.024.6 4 34.9 24.0 27.1 35.7 24.1 5 35.1 23.8 26.9 25.6 24.3 6 35.3 23.726.9 25.8 24.5 7 35.5 23.8 29.9 25.4 24.7 8 35.7 24.0 27.2 25.5 25.2 935.9 24.2 27.3 26.1 24.1 10 36.1 24.5 27.9 25.9 24.4 11 36.2 24.9 28.125.0 24.9 12 36.4 25.2 28.5 26.2 25.0 13 36.6 25.5 29.9 26.7 25.3 1436.8 25.8 29.4 27.0 25.9 15 37.0 26.2 29.7 27.3 25.0 16 37.1 26.5 30.027.7 26.3 17 37.3 26.0 30.5 28.1 26.5 18 37.5 27.1 30.8 28.5 26.8 1937.7 27.5 31.3 28.9 27.1 20 37.9 27.8 31.6 29.3 27.2 21 38.1 28.1 31.929.6 27.5 22 38.3 28.5 32.3 30.0 27.9 23 38.6 28.7 32.7 30.5 28.4 2438.8 29.1 32.9 30.6 28.7 25 39.0 29.5 33.3 30.8 28.9 26 39.2 29.8 33.531.2 29.1 27 39.4 30.1 34.1 31.5 29.5 28 39.5 30.5 34.4 31.7 29.8 2939.8 30.8 37.7 32.0 30.0 30 40.0 31.1 35.1 32.3 30.1

Samples A-E were compared with commercially available un-lined coldpacks from Medlogix Inc., P.O. Box 2157, Chester, Va. 23831 (productcode 10-01) (Standards A-E). The lots of un-lined commercially availablecode packs were comprised of urea and water. Standards A-E wereactivated by squeezing then shaking 10 times. The Standards were foldedand inserted into 16 oz Styrofoam cups. The ambient temperature, 68.7°F., was recorded and thermocouples were place in the fold of eachStandard about one inch from the bottom of the cups. Temperaturereadings were recorded once a minute with the last recording made after30 minutes. Each Standard was reshaken after a two minute elapsed time.The results are shown in Table II below:

TABLE II Time (min) Standard A Standard B Standard C Standard D StandardE 1 67.8 67.8 67.8 67.8 67.8 2 53.3 54.3 55.9 50.2 57.5 3 52.9 53.4 54.549.1 53.2 4 52.3 44.9 51.3 48.4 42.4 5 45.1 44.5 50.7 52.2 38.1 6 41.744.7 51.2 52.6 37.7 7 41.2 45.3 51.1 52.7 37.7 8 41.5 45.3 51.3 52.938.0 9 42.5 45.4 51.7 52.3 38.2 10 42.5 45.4 51.1 52.0 38.5 11 43.3 45.651.3 52.1 38.8 12 45.2 45.7 51.5 52.3 38.9 13 46.1 45.7 51.6 51.7 39.214 46.5 45.7 51.6 51.3 39.5 15 47.0 46.1 51.6 51.4 39.9 16 47.8 46.051.6 51.7 40.1 17 47.8 46.1 51.5 51.9 40.3 18 47.7 46.7 51.0 51.7 40.319 47.1 46.7 50.3 51.7 40.5 20 47.3 46.7 50.9 51.5 40.9 21 47.3 46.750.4 51.7 41.1 22 47.2 46.8 51.3 51.7 41.3 23 47.5 47.4 51.3 51.8 41.424 47.6 47.5 51.8 52.0 41.7 25 47.7 47.6 52.0 52.1 42.4 26 47.9 47.752.1 52.1 42.3 27 48.1 47.9 52.1 52.3 42.3 28 48.1 48.0 52.3 52.1 42.929 48.4 48.1 52.3 52.5 43.1 30 48.6 48.5 52.4 51.9 43.3

The standards were compared with the cooling elements by comparing theaverage temperatures at each time. The results are shown in Table III,below.

TABLE III Time (min) Excel Series 1 Medlogix Series 2 1 68.7 67.8 231.46 54.24 3 27.98 52.62 4 29.16 47.86 5 27.14 46.12 6 27.24 45.58 727.86 45.6 8 27.52 45.8 9 27.52 46.02 10 27.76 45.9 11 27.82 46.22 1228.26 46.72 13 28.8 46.86 14 28.98 46.92 15 29.04 47.2 16 29.52 47.44 1729.68 47.52 18 30.14 47.48 19 30.5 47.26 20 30.76 47.46 11 31.04 47.4412 31.4 47.66 13 31.78 47.88 14 32.02 48.12 15 32.3 48.36 16 32.56 48.4217 32.92 48.54 18 33.18 48.68 19 34.06 48.88 20 33.72 48.94

As shown in FIG. 5, the lined cooling element 52 (labeled as Series 1)surprisingly reached an average temperature of 31.46° F. within oneminute of being activated (as shown in FIG. 5 at minute 2). The coolingelement continues to cool to an average low of 27.14° F. within 4minutes of activation and remains under 35° F. for at least 30 minutes.By contrast, the control cold packs by Medlogix (FIG. 5, Series 2), evenwithout a lining layer, do not achieve the desired average temperaturewithin a minute of activation. Notably, the Medlogix cold packs, asshown in Series 2, did not reach the desired temperature, but remain atan average of between 45° F. and 50° F.

The cooling element 52 may also be used without the cooling collar 10 totreat pain or to impart selective brain cooling via the carotid arterieswhen head and neck injury are not suspected. In this embodiment, shownin FIG. 6, the cooling element may be used in a neck band configurationthat comprises a cooling element 52 and a left wing 62 and a right wing64 attached to each end of the cooling element. The cooling pack 52 maybe activated and placed over the patient's carotid arteries, with thewings 62, 64 may be wrapped around the patient's neck and attached toone another in the posterior of the neck with a suitable attachmentmechanism, such as a hook and loop fastener (not shown).

In another embodiment, the cooling element 52 may include one or moreendothermic packs, such as those containing compartments of ammoniumnitrate and water separated by rupturable membranes. In this embodiment,deforming the cooling elements 52 so as to apply differential pressurebetween the compartments or to otherwise break the membrane can activatesuch cooling elements 52.

In use, the cervical immobilization collar 10 is placed around apatient's neck, and the cooling element 52 is activated and placed inthe anterior opening 28. The door 30 is then closed over the coolingelement 52, securing the cooling element 52 between the door 30 and thepatient's neck. The cooling element 52 will generally overlie thecarotid arteries of the patient's neck and function as a heat extractorfor withdrawing heat from blood flowing through the patient's carotidarteries. Preferably, the cooling element 52 conforms to theparticularities of individual patient's necks, thereby maximizing skincontact area for more efficiently withdrawing heat from neck tissuesadjacent to the carotid arteries. In one embodiment, the cooling element52 conforms to the patient's neck by using pressure members 56 mountedon a body-facing surface of the door 30.

Specifically, as shown in FIG. 7, the door 30 has a body-facing surfaceand an outward-facing surface (shown in FIG. 2). As shown, thebody-facing surface includes two spaced-apart, pyramid-shaped pressuremembers 56 that extend toward the user. The pressure members 56 may beformed of other shapes, including blocks, tubes, or any other suitableshape extends toward the patient's neck when the door 30 is closed. Thepressure members 56 are placed on the body-facing surface in a positionthat, when the collar 10 is in use, exerts pressure on the coolingelement 52 to maximize skin contact in the carotid artery area. Thepressure members 56 may be integrally formed with the body-facingsurface of the door 30 or may be attached to the body-facing surface ofthe door 30 by suitable means, including an adhesive. Alternatively, thepressure member 56 may be integrally formed with the door 30. Thepressure members 56 may be made of foam, plastic, or other suitablematerial. In one embodiment, the pressure members 56 may be made of a2.8 lb. density open cell urethane foam. The pressure members 56 shouldbe formed so that the pressure exerted on the patient's carotid arteriesdoes not block the patient's airway.

As shown in FIG. 7, a foam layer 58 lines the body-facing surface of thesubstantially annular support structure 12 to provide a better fit withthe patient's neck. The foam layer may be formed of an open or closedcell foam, or other suitable material. In this embodiment, thesubstantially annular support structure 12 and the foam layer 58 includea rear, rectangular opening 60 within posterior portion 18 to provideaccess to the rear of the patient's neck in case there is a need foradditional medical procedures. In an alternative embodiment, there is noopening in the posterior portion 18 of the device.

It is also contemplated that the cervical immobilization collar mayincorporate a sensor (not shown) mounted in the vicinity of one of thepatient's carotid triangle for monitoring one or more circulatoryparameters such as arterial oxygen saturation, heart rate, bloodpressure, and blood temperature. For positioning the sensor in directcontact with the patient's skin, a portion of the cooling element mayneed to be reshaped or displaced. A recording device (not shown) can belocated elsewhere inside or outside the collar for recording informationcollected by the sensors. Other sensors can be mounted elsewhere in thecollar for monitoring various body parameters, including bodytemperature, or for monitoring performance of the immobilization collaritself. For example, a temperature gauge, such as a thermochromic strip,can be used for monitoring the temperature of the collar or the coolingelement.

A display (not shown) may be placed on the outside surface of theanterior portion of the same cervical immobilization collar. The displaycan be used for monitoring the circulatory data collected by the sensoras well as other data collected by other sensors mounted in the collar.A communications port (not shown) can also be formed in the collar fortransferring data from the one or more sensors to an external device.

The cervical immobilization collar makes possible a new protocol fortreating trauma patients, including patients suffering from head trauma,heart attack, ischemic attack, headache, epilepsy, heat stroke,concussion, or similar conditions. It is envisioned that the protocolmay be employed by emergency medical technicians or at hospitals, forhome use, by athletic trainers, or the like. The treatment centers oninstalling a cervical immobilization collar around a patient's neckhaving facility for limiting rotation and compaction of the patient'scervical vertebrae and using the cooling element with the collar toimpart selective cooling of the brain via the carotid arteries. Theprotocol uses vasodilatation of the patient's carotid arteries to evokeselective central core brain cooling and mild hypothermia, as opposed tosystemic cooling of the body. As opposed to smaller vessels of the body,which respond by constricting when cold is applied to the skin, thelarger blood vessels of the body appear to respond by dilating, allowingincreased cooled blood to circulate to the brain from the carotidarteries

The protocol includes determining the size of collar 10 that the patientrequires. Available sizes include conventional no neck, short, regular,and tall cervical immobilization collars. The collar 10 is then appliedto the patient and the door 30 is opened. The cooling element 52 is thenactivated by breaking the liquid filled packet and shaking the coolingelement 52 for about 15 to about 20 seconds. The cooling element 52 isthen placed in the anterior opening 28 in the frame of the substantiallyannular support structure 12 and secured to the patient's neck byclosing the door 30. The cooling element 52 is in thermal transcutaneouscommunication with at least one of the patient's carotid arteriesthrough an anterior portion of the patient's neck, thus initiating aflow of heat from the one or more carotid arteries through the anteriorportion of the patient's neck to the cooling element and the reducingtemperature of the patient's brain without inducing systemichypothermia.

The cooling element 52 should be left in place for approximately 20, butno more than 30 minutes, at which time the first cooling element shouldbe removed and a new cooling element activated and placed within thecollar as described above. This protocol may be repeated as needed.

The protocol can also include monitoring one or more parameters relatedto circulatory performance of the patient through one or more sensorscarried by the immobilization collar. The monitored parameters caninclude oxygen saturation, pulse rate, blood pressure, or bloodtemperature. Sensors can also be used to monitor the thermal performanceof the cooling element. The protocol of claim can also include measuringa pulse rate of the patient manually by temporarily displacing thecooling element from an opening in the collar over the patient's carotidtriangle.

Although the invention has been described with respect to a limitednumber of embodiments, many more variations will be readily apparent tothose of skill in the art in accordance with the overall teaching andscope of this invention. For example, the cooling elements could bemounted on both the anterior and posterior portions of the cervicalimmobilization collar to extract heat from larger portions of thepatients' necks. The cooling of both carotid arteries is generallypreferred, but the cooling elements could also be fashioned for coolingjust one of the carotid arteries, leaving the other carotid arteryexposed for other purposes.

1. A cooling element comprising: a body-facing panel, an outward-facing panel, and a cooling material disposed between the body-facing panel and the outward facing panel; wherein the cooling material is capable of producing a temperature of 20° F. to 35° F. within a minute of activation when measured on a body-facing surface of the body-facing panel.
 2. The cooling element of claim 1, wherein the cooling material maintains the temperature for a period of about 15 to about 30 minutes.
 3. The cooling element of claim 1, wherein the cooling material comprises Carbamakool.
 4. The cooling element of claim 1, wherein the cooling material comprises about 90 to about 110 g urea and about 45 to about 55 g Carbamakool.
 5. The cooling element of claim 1, wherein the cooling material comprises about 100 g urea and about 50 g Carbamakool.
 6. The cooling element of claim 1, wherein the cooling material comprises about 110 g urea and about 55 g Carbamakool.
 7. The cooling element of claim 1, wherein the cooling element further comprises a lining layer.
 8. The cooling element of claim 7, wherein the lining layer comprises non-woven material.
 9. The cooling element of claim 8, wherein the lining layer is attached to the body-facing surface of the body-facing panel.
 10. The cooling element of claim 9, wherein the body-facing panel is attached to the lining layer with an adhesive.
 11. The cooling element of claim 8, wherein the lining layer substantially covers the body-facing surface of the body-facing panel and an outward-facing surface of the outward-facing panel.
 12. A kit for cooling the blood in the carotid arteries comprising: a cooling element comprising a body-facing panel, an outward-facing panel, and a cooling material disposed between the body-facing panel and the outward facing panel; wherein the cooling material is capable of producing a temperature of 20° F. to 35° F. within a minute of activation when measured on the body-facing surface of the body-facing panel; and a cervical immobilization collar comprising a substantially annular support structure having an extended axial length and an anterior opening.
 13. The cooling element of claim 1, wherein the cooling material maintains the temperature for a period of about 15 to about 30 minutes.
 14. The cooling element of claim 1, wherein the cooling material comprises Carbamakool.
 15. The cooling element of claim 1, wherein the cooling material comprises about 90 to about 110 g urea and about 45 to about 55 g Carbamakool.
 16. The cooling element of claim 1, wherein the cooling material comprises about 100 g urea and about 50 g Carbamakool.
 17. The cooling element of claim 1, wherein the cooling material comprises about 110 g urea and about 55 g Carbamakool.
 18. The cooling element of claim 1, wherein the cooling element further comprises a lining layer.
 19. The kit of claim 12, wherein the cooling element is configured to be received in the anterior opening of the substantially annular support structure.
 20. The kit of claim 19, wherein the cooling element is capable of being secured within the anterior opening of the substantially annular support structure. 